Abstract
IntroductionClinical guidelines recommend extended treatment with dual antiplatelet therapy (DAPT) with ticagrelor 60 mg (twice daily) beyond 12 months in high‐risk patients with a history of myocardial infarction (MI) who have previously tolerated DAPT and are not at heightened bleeding risk. However, evidence on patterns of use and associated clinical outcomes in routine clinical practice is limited.MethodsALETHEIA is an observational, multi‐country study, designed to describe characteristics, treatment persistence, and bleeding and cardiovascular (CV) outcomes in post‐MI patients who initiate ticagrelor 60 mg in routine clinical practice (NCT04568083). The study will include electronic health data in the United States (US; Medicare, commercial claims) and Europe (Sweden, Italy, United Kingdom, Germany). Characteristics will be described among patients with and without ticagrelor 60 mg ≥1 year post‐MI. Assuming an a priori threshold of 5000 person‐years on‐treatment is met, to ensure sufficient precision, clinical outcomes (bleeding and CV events) among patients treated with ticagrelor 60 mg will be assessed. Risk factors for clinical outcomes and treatment discontinuation will be assessed in patients with ticagrelor 60 mg and meta‐analysis used to combine estimates across databases. Cohort selection will initiate from the ticagrelor 60 mg US and European approval dates and end February 2020. An estimated total of 7250 patients prescribed ticagrelor 60 mg are expected to be included.DiscussionAn increased understanding of patterns of ticagrelor 60 mg use and associated clinical outcomes among high‐risk patients with a prior MI is needed. The a priori specified stepwise approach adapted in this observational study is expected to generate useful evidence for clinical decision‐making and treatment optimization.
Highlights
Clinical guidelines recommend extended treatment with dual antiplatelet therapy (DAPT) with ticagrelor 60 mg beyond 12 months in high-risk patients with a history of myocardial infarction (MI) who have previously tolerated DAPT and are not at heightened bleeding risk
This paper presents the rationale and design of ALETHEIA, an observational study with the primary objective to describe patient characteristics, treatment persistence, and event rates of bleeding requiring hospitalization in a large multi-country cohort of patients treated with ticagrelor 60 mg after an MI
ALETHEIA aims to enhance the understanding of patient characteristics, treatment patterns, and bleeding and CV outcomes in patients with a history of MI on extended DAPT with ticagrelor 60 mg in routine clinical practice
Summary
Clinical guidelines recommend extended treatment with dual antiplatelet therapy (DAPT) with ticagrelor 60 mg (twice daily) beyond 12 months in high-risk patients with a history of myocardial infarction (MI) who have previously tolerated DAPT and are not at heightened bleeding risk. The DAPT study demonstrated that extending DAPT with either clopidogrel or prasugrel and ASA for up to 30 months following insertion of a drug-eluting stent for ACS or stable CAD reduced the risk of MACE (HR 0.71; 95% CI 0.59–0.85) and stent thrombosis (HR 0.29; 95% CI 0.17–0.48), compared to 12 months of DAPT, albeit with an increased risk of moderate or severe bleeding (2.5% vs 1.6%, p = .001).[5] Clinical guidelines recommend extending DAPT, with ticagrelor 60 mg preferred over clopidogrel or prasugrel, beyond 12 months in high-risk patients with a history of MI without previous bleeding complications or conditions associated with highrisk of major bleeding.[8,9,10]
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